Read: Bill of Rights for Trial Participants

[pegleg]

Having volunteered with the Parkinson Pipeline Project for several years and being a trial participant myself, we saw a need for a Bill of Rights.

Please see The Declaration of Clinical Research Rights and Responsibilities for People With Parkinson’s (PWP) at: http://www.pdpipeline.org/advocacy/rights.htm

The Parkinson Pipeline Project is beginning to seek endorsements for the Declaration among the various stakeholders in the clinical trial process, and your comments are welcomed.

The Declaration is intended to help speed the clinical trial process by encouraging more of our fellow PWP to participate and remain in clinical trials. Currently only 1% of PWP participate -- far below the number needed. This delays many promising trials for those of us who need a cure TODAY. Many of us do not have the average 17 years it takes for neurological treatments to make it through the drug development pipeline.

Among the factors that we believe discourage people from participating in trials are:
· A lack of awareness and understanding of the research process.
· Widespread public distrust of the pharmaceutical industry.
· Complicated and easily misunderstood informed consent documents.
· A system that asks clinical trial participants to accept considerable risks to their health and lives, but excludes them from the decision-making process.

To address these areas, the Parkinson Pipeline Project and other interested Parkinson's advocates, with the support of the Parkinson's Disease Foundation, developed the Declaration. It reflects the experiences of PWP who have participated in clinical trials and incorporates their suggestions for improving the process and the treatment of human trial participants. An accompanying guide/checklist of questions for patients considering clinical trial participation is also being developed.

We believe that acceptance of this Declaration and adherence to its principles by all stakeholders, will help to:

· Educate the Parkinson’s community about the clinical research process, and empower PWP to make more informed decisions about their participation.
· Improve communication and understanding, and create an atmosphere of mutual trust, respect, and collaboration among all stakeholders.
· Inspire a culture shift where the trial participant is viewed as a partner, not a passive subject in the clinical research process.
· Adopt shared decision-making processes for discontinuing investments in research or halting clinical trials.
· Protect the safety of trial participants more effectively.
· Clarify administrative and financial obligations for clinical trial participation.
· Increase participation in clinical trials to speed the evaluation and approval of new treatments that will ultimately bring us closer to that long-awaited cure for Parkinson’s disease.

Bringing about change to improve the clinical trial process requires the commitment of all stakeholders, which includes you. We encourage you to read this document, and consider the benefits it might provide to clinical trial participants. We welcome your comments. Please reply to the thread, or you can email me at: tnpeg@yahoo.com or leave a private message.

thank you!

Peggy
Parkinson Pipeline Project

[DJM]

Peg, I thought most of the conditions listed in the Pt Bill of Rts. were thoroughly covered in the drug study that I'm currently in. But the study I'm in is ending without ever being approved. And I feel my rights have been violated.

A couple of years ago, I felt so sorry for the Amgen PD trial participants when many who had been helped - not harmed - by it demanded the right to continue to receive the treatment. And that's where I am now - dreading the end of the study I'm in next month.

The KW-6002 (Istradefylline) drug study began as a double blind event for me. And, from the very first dose, I felt so much better! It was obvious to both the medical staff and to myself that I was getting the real drug - not a placebo. The experimental drug has helped me immensely. In fact, when the qualification parameters changed so that I no longer qualifed to be part of the study, my daily functioning declined considerably. The dramatic change in my well being on vs. off the drug led me to the decision to have surgery so as to once again qualify for the study.

Nearly two years of taking this med and I have had no negative reactions and a noticeable imiprovement in my daily functioning. Despite this drug helping me and a lot of other PD patients that I've spoken with, the study will end and the drug will no longer be available to me as of next month.

QUOTE:"The option for participants in the experimental/treatment group to continue the treatment. Likewise, those who received placebo or low dose treatments, or sham surgery should have the option of receiving the experimental treatment at the full dose, upon conclusion of their trial."

If I understand the quote above taken from the Trial Pts Bill of Rts., this bit means that drug study patients could opt to continue to take the study drug after the study ends and the study's sponsor would have to continue to produce the drug in quantities large enough to meet trial participant needs. I'm all for that!

I would sign whatever waiver they came up with to protect the drug company doing the study, but I should have the choice to continue the drug or not. This choice is not mine - I have no say in it. So, yes, Peg, I think the purpose of the Bill of Rts. is very necessary.

Considering this experience, will I participate in other drug studies that may arise? Maybe. Maybe not.

[franticfranny]

I just happened to look at Brain talk and see your post. I have participated in numerous trials for many reasons. I was diagnosed almost 3 years ago at 52. I am on disability from teaching, so I have very little money to contribute, but I am still able to take the train and bus to Chicago and be in the trials at Northwestern. I was also in several at Glenbrook hospital and went to Wisconsin for a Pet scan and MRI. I enjoy answering the questionaires. I am also a participant for my own children. My concerns are 1)if we have problems, our insurance has to pick up the tab: 2) I never get any results, explanation, or follow-up. 3) It takes months and lots of reminders to get reimbursed for travel. I still haven't gotten my $14.30 from January. I am taking Creatine and have gained over 30 lbs. I really want to stop because of the weight gain, but I feel guilty. Also, I think it's helping me move better. I was surprised to learn that 1% of patients participate in trials. Thanks for posting. Let me know if I can help. e-mail Franny623@aol.com.

[Chicory]

I am one who had the opportunity to participate in a trial and chose not to- the primary reason is time. I am still working part time and my life is very busy, especially since I need time for a nap every day to be able to do everything. I felt that the trial required too many trips into Philadelphia and when I go by train, it takes 1 1/2 hours each way.

Chicory

[pegleg]

you may notice that this initial post was written in 2006. Read our finished product now called the Declaration of Rights & Responsibilities for Clinical Trials

www.pdpipeline.org (mid-way on the page)

Peggy